Annual General Meeting Tuesday, 28 th April 2009

1. Annual General MeetingTuesday, 28th April 2009 Meeting the Challenges of 2009 and beyond...

2. MY PRESENTATION TODAY: • 1) The HFMA – some background • 2) What are the challenges? • How do we confront and combat • them? • 4) Conclusions

3. WHAT IS THE HFMA? • The voice of the UK’s Natural Products industry • The most representative trade body in the UK, founded in 1965. Currently around 125 members • Founder member of EHPM, the European Federation of Health Product Manufacturers

4. ‘WHO’ IS THE HFMA? HFMACouncil – 2009/10: HFMA Secretariat: Executive Director: Graham Keen Special Projects Director: David Adams Office Manager: Linda Phillips Company: Capsugel Cress Gee Lawson Holland & Barrett Lamberts Healthcare G R Lane MPL Marketing Natures Aid Reaction Sales CL UK Vitabiotics William Ransom Wassen Represented by: Gert Krabichler Dominic Holmes Jonathan Shorts Roger Craddock John Redman Janet Groves Martin Last Lynn Lord Tom Moses Robert Taylor Ivor Harrison Tim Snook LAPAD Code Administrator: Gwyneth Massey Code Administrator: Jenny Akers Advisers: Technical: Michael Evans Scientific: Dr Michele sadler Parliamentary/Political: Chris Whitehouse PR: Pegasus PR Officials: President: Peter Aldis Vice-President: Penny viner Expert Panel: Dr Marilyn Glenville PhD Professor Andrew Lotery Jayney Goddard Dr Adam Carey Patrick Holford Dr Rob Hicks

8. SO WHAT ARE THE CHALLENGES? • Regulatory Issues • Combating negative media • Getting the rest of Europe up to speed! • Getting our Officials to fight harder on our behalf • Maintaining a united front

9. SO WHAT ARE THE CHALLENGES? • Regulatory Issues • Combating negative media • Getting the rest of Europe up to speed! • Getting our Officials to fight harder on our behalf • Maintaining a united front

10. ISSUES FSD CLAIMS HERBALS UIC

11. PROGRESS IN 2008 • MPL’s – HFMA lobbying, using impact data and legal arguments, helped delay EU proposals • Claims – HFMA supported 776 pan-EU claims • Herbals – Steady increase in THMPD applications & recognition by EFSA that the ‘Botanicals’ category exists • UIC – Guernsey introduced new Medicines law, Jersey committed to implementing legislation

12. STILL TO FIGHT • MPL’s - Commission favours political compromise & UK ‘sacrifice’ • Claims – Chronic lack of clarity on several issues & criteria for assessment by EFSA • Herbals – THMPD barriers to entry for SME’s (cost) = reduced consumer choice & Botanicals meeting NHCR criteria for making claims • UIC – Enforcement is required to ensure effectiveness of new laws

13. SO WHAT ARE THE CHALLENGES? • Regulatory Issues • Combating negative media • Getting the rest of Europe up to speed! • Getting our Officials to fight harder on our behalf • Maintaining a united front

14. PR • The perpetual dilemma: • Reactive vsproactive? • Proactive PR needs quality ‘ammunition’: • The IADSA/EHPM Scientic Network initiative

15. SO WHAT ARE THE CHALLENGES? • Regulatory Issues • Combating negative media • Getting the rest of Europe up to speed! • Getting our Officials to fight harder on our behalf • Maintaining a united front

16. IMPACTING BRUSSELS: • DG meetings • MEP consultations • National Permanent Representatives • Commission processes e.g. Petitions • Pre-election lobbying (see the HFMA’s latest toolkit) Key point to remember – Brussels is currently fixated on SME impact

17. SO WHAT ARE THE CHALLENGES? • Regulatory Issues • Combating negative media • Getting the rest of Europe up to speed! • Getting our Officials to fight harder on our behalf • Maintaining a united front

18. HOW DO WE DO THIS? • A concerted campaign: • Face-to-face meetings/telephone updates (during our recent MPL’s campaign we met with the Health Minister, Defra, BERR, FSA, along with DG SANCO, DG Enterprise, MEP’s and the UK Perm Rep) • Parliamentary briefings • Briefing papers • Remember - they need our help to properly fight our case...

19. SO WHAT ARE THE CHALLENGES? • Regulatory Issues • Combating negative media • Getting the rest of Europe up to speed! • Getting our Officials to fight harder on our behalf • Maintaining a united front

20. A UNITED FRONT • Consumers • Retailers • Other national associations (where we have agreement and consensus) • A lead role within Europe • Our closest ally in Europe

21. FUNDAMENTAL PRINCIPLES: “The four tenets of safety, sound science, proportionality and consumer choice must be the basis in future upon which regulation is founded” John Redman, HFMA Chairman – 6/4/09

22. THE KEY MESSAGE: • Over-regulation risks suffocating a responsible and innovative sector that is populated predominantly by small and medium sized enterprises • Over-regulation risks driving consumers to the grey and unregulated markets of the internet and offshore suppliers, ironically reducing not enhancing consumer protection • Over-regulation of the self-care sector risks impacting upon public health and increasing the burdens on the Health Service Executive/National Health Service • Over-regulation brings the European Commission into disrepute and does a disservice to the people it serves

23. IN CONCLUSION... • There is not a part of our industry that will not be impacted by over-regulation • This will not be easy – we are only 2 members out of a club of 27... • We cannot duck these challenges!